Pharmacyclics plans to submit a New Drug Application (NDA) to the US FDA to market Xcytrin (motexafin gadolinium) injection for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases (i.e., lung cancer that has spread to the brain from another part of the body).

The company also announced that new analyses and additional data from its phase 3 SMART (Study of Neurologic Progression with Motexafin Gadolinium And Radiation Therapy) trial will be presented at the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta.

"We plan to file an NDA for Xcytrin primarily based on the data from our pivotal SMART trial," Richard A. Miller, president and CEO of Pharmacyclics said adding, "New data from the SMART trial, which will be included in the NDA filing, will be presented and discussed at ASCO. We anticipate filing the Xcytrin NDA by the end of 2006."

Pharmacyclics is developing Xcytrin as an anti-cancer agent with a novel mechanism of action that is designed to selectively concentrate in tumours and induce apoptosis (programmed cell death). Xcytrin is a redox-active drug that has been shown to disrupt redox-dependent pathways in cells and inhibit oxidative stress related proteins. Its multifunctional mode of action provides the opportunity to be used in a broad range of cancers. Xcytrin has been granted Fast Track designation by the FDA for use in the treatment of lung cancer brain metastases. This designation is reserved for new drugs that demonstrate the potential to address an unmet medical need and are intended for the treatment of a serious or life-threatening condition.

Pharmacyclics is a pharmaceutical company, its lead product, Xcytrin, has completed Phase 3 clinical testing in lung cancer brain metastases and several Phase 1 and Phase 2 clinical trials are ongoing with Xcytrin, either as a single agent or in combination with chemotherapy and/or radiation in multiple cancer types.